JMIR Diabetes最新文献

Background: Black adolescents with type 1 diabetes (T1D) are at increased risk for suboptimal diabetes health outcomes; however, evidence-based interventions for this population are lacking. Depression affects a high percentage of youth with T1D and increases the likelihood of health problems associated with diabetes.

Objective: Our aim was to test whether baseline levels of depression moderate the effects of a brief eHealth parenting intervention delivered to caregivers of young Black adolescents with T1D on youths' glycemic control.

Methods: We conducted a multicenter randomized controlled trial at 7 pediatric diabetes clinics located in 2 large US cities. Participants (N=149) were allocated to either the intervention group or a standard medical care control group. Up to 3 intervention sessions were delivered on a tablet computer during diabetes clinic visits over a 12-month period.

Results: In a linear mixed effects regression model, planned contrasts did not show significant reductions in hemoglobin A_1c (HbA_1c) for intervention adolescents compared to controls. However, adolescents with higher baseline levels of depressive symptoms who received the intervention had significantly greater improvements in HbA_1c levels at 6-month follow-up (0.94%; P=.01) and 18-month follow-up (1.42%; P=.002) than those with lower levels of depression. Within the intervention group, adolescents had a statistically significant reduction in HbA_1c levels from baseline at 6-month and 18-month follow-up.

Conclusions: A brief, culturally tailored eHealth parenting intervention improved health outcomes among Black adolescents with T1D and depressive symptoms.

Trial registration: ClinicalTrials.gov NCT03168867; https://clinicaltrials.gov/study/NCT03168867.

Background: Digital health programs provide individualized support to patients with chronic diseases and their effectiveness is measured by the extent to which patients achieve target individual clinical outcomes and the program's ability to sustain patient engagement. However, patient dropout and inequitable intervention delivery strategies, which may unintentionally penalize certain patient subgroups, represent challenges to maximizing effectiveness. Therefore, methodologies that optimize the balance between success factors (achievement of target clinical outcomes and sustained engagement) equitably would be desirable, particularly when there are resource constraints.

Objective: Our objectives were to propose a model for digital health program resource management that accounts jointly for the interaction between individual clinical outcomes and patient engagement, ensures equitable allocation as well as allows for capacity planning, and conducts extensive simulations using publicly available data on type 2 diabetes, a chronic disease.

Methods: We propose a restless multiarmed bandit (RMAB) model to plan interventions that jointly optimize long-term engagement and individual clinical outcomes (in this case measured as the achievement of target healthy glucose levels). To mitigate the tendency of RMAB to achieve good aggregate performance by exacerbating disparities between groups, we propose new equitable objectives for RMAB and apply bilevel optimization algorithms to solve them. We formulated a model for the joint evolution of patient engagement and individual clinical outcome trajectory to capture the key dynamics of interest in digital chronic disease management programs.

Results: In simulation exercises, our optimized intervention policies lead to up to 10% more patients reaching healthy glucose levels after 12 months, with a 10% reduction in dropout compared to standard-of-care baselines. Further, our new equitable policies reduce the mean absolute difference of engagement and health outcomes across 6 demographic groups by up to 85% compared to the state-of-the-art.

Conclusions: Planning digital health interventions with individual clinical outcome objectives and long-term engagement dynamics as considerations can be both feasible and effective. We propose using an RMAB sequential decision-making framework, which may offer additional capabilities in capacity planning as well. The integration of an equitable RMAB algorithm further enhances the potential for reaching equitable solutions. This approach provides program designers with the flexibility to switch between different priorities and balance trade-offs across various objectives according to their preferences.

Background: Diabetes and hypertension are some of the most prevalent and costly chronic conditions in the United States. However, outcomes continue to lag behind targets, creating further risk of long-term complications, morbidity, and mortality for people living with these conditions. Furthermore, racial and ethnic disparities in glycemic and hypertension control persist. Flexible telehealth programs leveraging asynchronous care allow for increased provider access and more convenient follow-up, ultimately improving critical health outcomes across demographic groups.

Objective: We aim to evaluate the 12-month clinical outcomes of participants in the 9amHealth web-based clinic for diabetes and hypertension. We hypothesized that participation in the 9amHealth program would be associated with significant improvements in glycemic and blood pressure (BP) control across a diverse group of individuals.

Methods: We enrolled 95 patients in a completely web-based care clinic for diabetes and hypertension who received nutrition counseling, health coaching, and asynchronous physician consultations for medication prescribing. Patients received standard or cellular-connected glucose meters and BP cuffs in order to share data. Laboratory tests were completed either with at-home phlebotomy draws or a self-administered test kit. Patients' first and last hemoglobin A_1c (HbA_1c) and BP results over the 12-month period were compared, and analyses were repeated across race and ethnicity groups.

Results: Among all 95 patients, the average HbA_1c decreased by -1.0 (from 8.2% to 7.2%; P<.001) over 12 months of program participation. In those with a baseline HbA_1c >8%, the average HbA_1c decreased by -2.1 (from 10.2% to 8.1%; P<.001), and in those with a baseline HbA_1c >9%, the average HbA_1c decreased by -2.8 (from 11% to 8.2%; P<.001). Among participants who identified as a race or ethnicity other than White, the HbA_1c decreased by -1.2 (from 8.6% to 7.4%, P=.001). Further examination of subgroups confirmed HbA_1c lowering within each race or ethnicity group. In the overall population, the average systolic BP decreased by 17.7 mm Hg (P=.006) and the average diastolic BP decreased by 14.3 mm Hg (P=.002). Among participants self-identifying as a race or ethnicity other than White, the results similarly showed a decrease in BP (average reduction in systolic BP of 10 mm Hg and in diastolic BP of 9 mm Hg).

Conclusions: A fully web-based model leveraging all-asynchronous physician review and prescribing, combined with synchronous and asynchronous coaching and nutrition support, was associated with clinically meaningful improvement in HbA_1c and BP control over a 12-month period among a diverse group of individuals. Further studies should prospectively evaluate th

Background: Patients with type 2 diabetes mellitus (T2DM) experience multiple barriers to improving self-management. Evidence suggests that motivational interviewing (MI), a patient-centered communication method, can address patient barriers and promote healthy behavior. Despite the value of MI, existing MI studies predominantly used face-to-face or phone-based interventions. With the growing adoption of smartphones, automated MI techniques powered by artificial intelligence on mobile devices may offer effective motivational support to patients with T2DM.

Objective: This study aimed to explore the perspectives of patients with T2DM on the acceptability of app-based MI in routine health care and collect their feedback on specific MI module features to inform our future intervention.

Methods: We conducted semistructured interviews with patients with T2DM, recruited from public primary care clinics. All interviews were audio recorded and transcribed verbatim. Thematic analysis was conducted using NVivo.

Results: In total, 33 patients with T2DM participated in the study. Participants saw MI as a mental reminder to increase motivation and a complementary care model conducive to self-reflection and behavior change. Yet, there was a sense of reluctance, mainly stemming from potential compromise of autonomy in self-care by the introduction of MI. Some participants felt confident in their ability to manage conditions independently, while others reported already making changes and preferred self-management at their own pace. Compared with in-person MI, app-based MI was viewed as offering a more relaxed atmosphere for open sharing without being judged by health care providers. However, participants questioned the lack of human touch, which could potentially undermine a patient-provider therapeutic relationship. To sustain motivation, participants suggested more features of an ongoing supportive nature such as the visualization of milestones, gamified challenges and incremental rewards according to achievements, tailored multimedia resources based on goals, and conversational tools that are interactive and empathic.

Conclusions: Our findings suggest the need for a hybrid model of intervention involving both app-based automated MI and human coaching. Patient feedback on specific app features will be incorporated into the module development and tested in a randomized controlled trial.

Background: This exploratory study compares self-reported COVID-19 vaccine side effects and breakthrough infections in people who described themselves as having diabetes with those who did not identify as having diabetes.

Objective: The study uses person-reported data to evaluate differences in the perception of COVID-19 vaccine side effects between adults with diabetes and those who did not report having diabetes.

Methods: This is a retrospective cohort study conducted using data provided online by adults aged 18 years and older residing in the United States. The participants who voluntarily self-enrolled between March 19, 2021, and July 16, 2022, in the IQVIA COVID-19 Active Research Experience project reported clinical and demographic information, COVID-19 vaccination, whether they had experienced any side effects, test-confirmed infections, and consented to linkage with prescription claims. No distinction was made for this study to differentiate prediabetes or type 1 and type 2 diabetes nor to verify reports of positive COVID-19 tests. Person-reported medication use was validated using pharmacy claims and a subset of the linked data was used for a sensitivity analysis of medication effects. Multivariate logistic regression was used to estimate the adjusted odds ratios of vaccine side effects or breakthrough infections by diabetic status, adjusting for age, gender, education, race, ethnicity (Hispanic or Latino), BMI, smoker, receipt of an influenza vaccine, vaccine manufacturer, and all medical conditions. Evaluations of diabetes medication-specific vaccine side effects are illustrated graphically to support the examination of the magnitude of side effect differences for various medications and combinations of medications used to manage diabetes.

Results: People with diabetes (n=724) reported experiencing fewer side effects within 2 weeks of vaccination for COVID-19 than those without diabetes (n=6417; mean 2.7, SD 2.0 vs mean 3.1, SD 2.0). The adjusted risk of having a specific side effect or any side effect was lower among those with diabetes, with significant reductions in fatigue and headache but no differences in breakthrough infections over participants' maximum follow-up time. Diabetes medication use did not consistently affect the risk of specific side effects, either using self-reported medication use or using only diabetes medications that were confirmed by pharmacy health insurance claims for people who also reported having diabetes.

Conclusions: People with diabetes reported fewer vaccine side effects than participants not reporting having diabetes, with a similar risk of breakthrough infection.

Trial registration: ClinicalTrials.gov NCT04368065; https://clinicaltrials.gov/study/NCT04368065.

Background: Neuropathic foot ulcers are the leading cause of nontraumatic foot amputations, particularly among patients with diabetes. Traditional methods of monitoring and managing these patients are periodic in-person clinic visits, which are passive and may be insufficient for preventing neuropathic foot ulcers and amputations. Continuous remote temperature monitoring has the potential to capture the critical period before the foot ulcers develop and to improve outcomes by providing real-time data and early interventions. For the first time, the effectiveness of such a strategy to prevent neuropathic foot ulcers and related complications among high-risk patients in a real-world commercial setting is reported.

Objective: This study aims to evaluate the effectiveness of a real-world continuous remote temperature monitoring program in preventing neuropathic foot ulcers and amputations in patients with diabetes.

Methods: In this retrospective analysis of a real-world continuous remote temperature monitoring program, 115 high-risk patients identified by clinical providers from 15 geographically diverse private podiatry offices were analyzed. Patients received continuous remote monitoring socks as part of the program. The enrollment was based on medical necessity as decided by their managing physician. We evaluated data from up to 2 years before enrollment and up to 3 years during the program. The primary outcome was the rate of wound development. Secondary outcomes included amputation rate, the severity of the foot ulcers, and the number of visits to an outpatient podiatry clinic after enrolling in the program.

Results: We observed significantly lower rates of foot ulceration (relative risk reduction [RRR] 0.68; 95% CI 0.52-0.79; number needed to treat [NNT] 5.0; P<.001), less moderate to severe ulcers (RRR 0.86; 95% CI 0.70-0.93; NNT 16.2; P<.001), less amputations (RRR 0.83; 95% CI 0.39-0.95; NNT 41.7; P=.006), and less hospitalizations (RRR 0.63; 95% CI 0.33-0.80; NNT 5.7; P<.002). We found a decrease in outpatient podiatry office visits during the program (RRR 0.31; 95% CI 0.24-0.37; NNT 0.46; P<.001).

Conclusions: Our findings suggested that a real-world continuous remote temperature monitoring program was an effective strategy to prevent foot ulcer development and nontraumatic foot amputation among high-risk patients.

Background: In recent years, technologies promoting the digitization of self-monitoring of blood glucose (SMBG) records including app-cloud cooperation systems have emerged. Studies combining these technological interventions with support from remote health care professionals have reported improvements in glycemic control.

Objective: To assess the use of an app-cloud cooperation system linked with SMBG devices in clinical settings, we evaluated its effects on outpatient management of diabetes without remote health care professional support.

Methods: In this multicenter, open-label, and single-armed prospective study, 48 patients with diabetes (including type 1 and type 2) at 3 hospitals in Japan treated with insulin or glucagon-like peptide 1 receptor agonists and performing SMBG used the app-cloud cooperation system for 24 weeks. The SMBG data were automatically uploaded to the cloud via the app. The patients could check their data, and their attending physicians reviewed the data through the cloud prior to the patients' regular visits. The primary outcome was changes in glycated hemoglobin (HbA_1c) levels.

Results: Although HbA_1c levels did not significantly change in all patients, the frequency of daily SMBG following applying the system was significantly increased before induction at 12 (0.60 per day, 95% CI 0.19-1.00; P=.002) and 24 weeks (0.43 per day, 95% CI 0.02-0.84; P=.04). In the subset of 21 patients whose antidiabetic medication had not been adjusted during the intervention period, a decrease in HbA_1c level was observed at 12 weeks (P=.02); however, this significant change disappeared at 24 weeks (P=.49). The Diabetes Treatment Satisfaction Questionnaire total score and "Q4: convenience" and "Q5: flexibility" scores significantly improved after using the system (all P<.05), and 72% (33/46) patients and 76% (35/46) physicians reported that the app-cloud cooperation system helped them adjust insulin doses.

Conclusions: The digitization of SMBG records and sharing of the data by patients and attending physicians during face-to-face visits improved self-management in patients with diabetes.

Trial registration: Japan Registry of Clinical Trials (jRCT) jRCTs042190057; https://jrct.niph.go.jp/en-latest-detail/jRCTs042190057.